Summary

As an integral member of the research team, the Research Area Specialist (RAS) will help ensure that clinical research studies supported by the Department of Ophthalmology [under the helm of the University of Michigan Kellogg Clinical Research Center (KCRC)] are initiated and executed in the highest quality and compliant manner. In order to succeed, the applicant must possess exceptional organizational skills, uncompromising integrity, a love of people, ability to work independently, and a strong willingness to learn new skills. The ideal candidate for this position will support study needs for Investigator-initiated studies in a manner compliant with university and government policies and regulations. 

The RAS will be expected to work independently and gather applicable knowledge on various research endeavors as they arise, including multi-site studies where UM is the clinical and/or data coordinating center, internal and external requirements for PI-initiated studies that meet the definition of clinical trial (and their associated reporting systems), and best practices for sample study tracking and management. The RAS will be able to create processes for many aspects of these activities, among others, and train department research staff as needed to conduct these processes in a compliant manner.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems.  In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Responsibilities*

PROCESS DEVELOPMENT, IMPROVEMENT, AND INSTRUCTION: The RAS is expected to facilitate communications between researchers, research volunteers, regulatory personnel, and other key contributors. The communications will include, but will not be limited to, scheduling appointments, meeting with researchers, interfacing with regulatory and financial authorities, recruiting and retaining study participants in person and through phone, mailings, and other electronic mediums, working closely with study monitors if applicable, and resolving issues that invariably arise.  

Under this helm, the RAS will also: 

• Assist with the development and conduct of research projects according to needs that are specific to the Department of Ophthalmology, including studies involving genetics, sample collection and analysis, testing, and imaging.
  Act as liaison to other research-related units within UM, such as CTSU, HPSCRO, ORSP, and IBC to inform and train department researchers on applicable guidance and processes, completion of applications, and use of specified systems such as OnCore and ClinicalTrials.gov. 
• Collaborate with the department’s Compliance Specialist to operationalize the conduct of PI-initiated clinical trials, including multi-site studies where UM will be the clinical and/or data coordinator center. 
• Develop suitable processes for conducting complex sample collection studies and assist in the development of databases to accurately account for these samples. 
• Initiate processes for new studies and provide oversight for their day-to-day operations, including creation of SOPs add MOPs; onboard new research coordinators to take over these projects as needed. 

SPECIMEN AND DATABASE MANAGEMENT: A portion of this position will involve working with tissue samples and managing both databases and consent documents for these samples, and creating Standard Operating Procedures and processes to manage them that can be extended to other sample repositories within the department. The RAS will be expected to learn appropriate processing, storage, shipping techniques and regulations as needed. The RAS will need to become competent in abstracting accurate information from the medical record. This individual will also need to become competent in creating databases and spreadsheets that best fit study needs and will ensure that the samples are used and shared only as permitted by the protocol and university policy. 

REGULATORY COMPLIANCE: The ideal candidate for this position will have or be willing to accumulate advanced knowledge of regulations as they pertain to investigator-initiated studies, and become a resource for others in this regard. Employees of the KCRC follow all local, state, and federal regulations regarding clinical research in addition to Good Clinical Practice and protocol specific guidelines. A thorough knowledge of HIPAA and human subjects research regulations will be necessary for this role. The RAS is expected to actively support an environment of strict regulatory compliance.      

PROTOCOL-SPECIFIC NEEDS: The RAS is expected to possess a willingness to learn protocol-specific requirements, including, but not limited to, use of specialized camera and testing equipment, sample-specific processing and storage, and record-keeping.

OTHER: Clinical research regulations and best practices are frequently changing. The RAS is expected to incorporate these changes into the workflow as they occur. Many of the studies in which the RAS will be involved will require learning unique ways of tracking study activity, including specially-designed databases and reporting systems. The RAS will ensure studies remain compliant with standards of applicable agencies that may provide funding and will need to assist in reporting and preventing protocol deviations for studies that involve novel approaches.  

Required Qualifications*

Research Area Specialist Inter

• Bachelor’s Degree is required.  
• 4-5 years of experience in a related field.  
• Master’s Degree or Doctoral Degree preferred.
• Committed to prioritizing the welfare of the research volunteer.
• Exceptional organizational skills
• Exceptional attention to detail
• Uncompromising integrity
• Capacity to learn new skills as the positional needs change.
• Ability to work both independently and as part of a team.
• Experience with MS Word, Excel, Power Point, Outlook or equivalent.
• Experience with managing databases and human-derived samples, or willingness to learn.
• Experience with creating databases in RedCap or willing to learn.  
• Willingness to process human specimens, which may require wearing full proper lab attire.  

Research Area Specialist Assoc

• Bachelor’s Degree is required. 
• 1-3 years of experience in a related field.  
• Master’s Degree Preferred.
• Committed to prioritizing the welfare of the research volunteer.
• Exceptional organizational skills
• Exceptional attention to detail
• Uncompromising integrity
• Capacity to learn new skills as the positional needs change.
• Ability to work both independently and as part of a team.
• Experience with MS Word, Excel, Power Point, Outlook or equivalent.
• Experience with managing databases and human-derived samples, or willingness to learn.
• Experience with creating databases in RedCap or willing to learn.  
• Willingness to process human specimens, which may require wearing full proper lab attire.  

Desired Qualifications*

• Knowledge of general clinical research operations and regulations or a capacity to learn quickly.
• Experience working in eResearch, including creating new applications, amendments, submitting renewals, and creating informed consent and other study-related documents, or willingness to learn.
• Experience with genetics research practices and regulations, Institutional Biosafety policy, and sample shipping requirements or willingness to learn. 
• Experience with the MiChart (Epic) electronic health record (EHR) system.
• Experience with the OnCore clinical trial management system (CTMS) and understanding sponsored contracts, unfunded agreements (MTAs and DUAs), or willingness to learn.
• Willingness to achieve professional certification such as SOCRA or equivalent.
• Experience in eye testing that may include touching the surface of the eye with testing instruments, or willingness to do so if a study need arises.
• Ability to draw blood, or willingness to learn.

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

U-M COVID-19 Vaccination Policy

COVID-19 vaccinations, including one booster when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine.  This includes those working remotely and temporary workers.   More information on this new policy is available on the U-M Health Response website or the UM-Dearborn and UM-Flint websites.